Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Length of gestation
研究概览
简要总结
The purpose of this study is to determine whether fluoride supplementation during pregnancy is effective in extending the length of gestation and improving overall perinatal well-being.
详细描述
The Centers for Disease Control and Prevention (CDC) reports that preterm birth affected about 1 in 10 infants born in the United States in 2015. These statistics emphasize the significance of implementing a safe and effective therapy into routine clinical care aimed at reducing the rate of preterm birth. There has been evidence to suggest that fluoride supplementation to women during pregnancy can provide other medical benefits, in addition to a reduction in dental caries.
Fluoride is recognized by the Food and Nutrition Board (F&NB) of the American Academy of Sciences and the Food & Drug Administration (FDA) as an essential ion due to its association with a reduction in dental caries.
Upon entering the body, fluoride is taken up into the bones/calcified tissues, and excreted by the kidneys. When supplied during pregnancy in small aliquots, as with water fluoridation, the fluoride is likely taken up in the mother's bones and excreted by her kidneys so rapidly, that the fetus is denied a meaningful amount of fluoride, unless it is supplied in a pulse dose by supplement. The Institute of Medicine's Food and Nutrition Board recommends 3 mg/day for Adequate Intake in pregnancy and deems 10 mg/day as the Upper Limit.
After several papers elucidating an association between poor dentition, periodontal disease, and preterm birth, subsequent RCT's of regular periodontal scaling and treatment during pregnancy are still inconclusive in regards to preterm birth.
The investigators hypothesize that fluoride supplementation during pregnancy may have a beneficial effect on the natural microbiome of the maternal oral cavity and genital tract, capable of protecting against transient bacteremia and ascending infection, respectively, which are known antecedents to both preterm labor and preterm premature rupture of membranes. The research team predicts that the testing and analysis of specimens collected will demonstrate microbiome changes toward a more favorable profile not associated with preterm birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are between 10-20 weeks gestational age at the time of recruitment
- •Delivery at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center
排除标准
- •Use of prescription strength, high dose fluoride products (greater than 0.76% of fluoride), prescribed by a dental professional (toothpastes, mouthwashes, topical treatments). All over-the-counter toothpaste and mouthwash products are acceptable to use.
- •Occupational exposure to fluoride.
- •The daily amount of fluoride ingested should not exceed 10 mg/day, according to the Institute of Medicine and the FDA. Any participants consuming amounts of fluoride close to 10 mg/day will be excluded.
研究组 & 干预措施
Fluoride prenatal vitamin
Prenatal vitamin-mineral containing 3 mg fluoride
干预措施: Prenatal vitamin-mineral containing 3 mg fluoride (Drug)
Standard prenatal vitamin
Prenatal vitamin-mineral containing 0 mg fluoride
干预措施: Prenatal vitamin-mineral containing 0 mg fluoride (Dietary Supplement)
结局指标
主要结局
Length of gestation
时间窗: Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study
the length of gestation will be measured in weeks at time of delivery
次要结局
- Birth length(Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study)
- Birth weight(Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study)
- Preterm birth(Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study)
- Preterm premature rupture of membranes (PPROM)(Participants will be followed from the time of study enrollment until delivery, up to 30 weeks total in the study)